DOCSLIB.ORG

Optumrx Brand Pipeline Forecast

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Optumrx Brand Pipeline Forecast RxOutlook® 3rd Quarter 2018 OptumRx brand pipeline forecast Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug 2018 Possible launch date Eosinophilic FastTrk/ 2018 - SHP-621 budesonide Shire corticosteroid PO Y Y esophagitis Breakthru 2019 human ProMetic/ Ryplazim plasminogen Plasminogen deficiency IV Filed BLA 2H2018 Y Y plasminogen Hematech testosterone Clarus Jatenzo androgen Hypogonadism PO Filed NDA 2H2018 N N (CLR-610) Therapeutics Immune Remune HIV-1 vaccine Response vaccine HIV IM Filed BLA 2H2018 Y Y BioPharma promethazine/ Charleston anti-emetic/ opioid/ Hydexor hydrocodone/ Nausea/ Vomiting/ Pain PO Filed NDA 2H2018 N N Laboratories analgesic acetaminophen Takeda/ lubiprostone lubiprostone chloride channel activator Constipation PO Filed NDA 2H2018 N N Sucampo tacrolimus Filed Astagraf XL (extended- Astellas immunosuppressant Organ transplantation PO 2H2018 Y N sNDA release) Numbrino cocaine HCl Lannett anesthetic Anesthesia TOP Filed NDA 2H2018 N N Parkinson's disease Nuplazid pimavanserin Acadia 5-HT-2A receptor agonist PO InTrial 2H2018 Y N (PD) psychosis selective progesterone Ella ulipristal acetate Allergan Uterine bleeding PO Filed NDA 3Q2018 N N receptor modulator (SPRM) optum.com/optumrx 1 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Arakoda tafenoquine 60 degrees apoptosis modulator Malaria PO Filed NDA 3Q2018 N N Aquestive AQST-120 clobazam benzodiazepine Seizures PO Filed NDA 3Q2018 N N Therapeutics moxetumomab moxetumomab MedImmune CD22 antigen inhibitor Hairy cell leukemia IV Filed BLA 3Q2018 Y Y pasudotox pasudotox calcitonin gene-related Migraine prevention/ galcanezumab- LY-2951742 Eli Lilly/ Arteaus peptide (CGRP) receptor Cluster headache SC Filed BLA 3Q2018 N N gnlm antagonist prevention oxycodone Pain Remoxy ER mu-opioid receptor agonist Pain PO Filed NDA 8/7/2018 N N extended-release Therapeutics Dr. Reddy's Tentative Zenavod doxycycline tetracyclines Rosacea PO 8/7/2018 N N Laboratories Approval Attention deficit methylphenidate Highland Benjorna CNS stimulant hyperactivity disorder PO Filed NDA 8/8/2018 N N modified-release Therapeutics (ADHD) ALN-TTR02 Alnylam/ Ionis/ (GENZ438027, patisiran RNAi therapeutic Polyneuropathy IV Filed NDA 8/11/2018 Y Y Sanofi/ Tekmira SAR438027) Galafold alpha-galactosidase A (Amigal, HGT- migalastat Amicus/ GSK Fabry disease PO Filed NDA 8/13/2018 Y Y enhancer 3310, AT-1001) Stanate stannsoporfin Mallinckrodt heme oxygenase inhibitor Hyperbilirubemia IM Filed NDA 8/22/2018 Y N loteprednol Dry eyes/ Ocular Inveltys Kala corticosteroid OP Filed NDA 8/24/2018 N N etabonate MPP inflammation Hereditary angioedema DX-2930 lanadelumab Dyax kallikrein inhibitor SC Filed BLA 8/26/2018 Y Y (HAE) IDP-121 tretinoin Valeant retinoid Acne vulgaris TOP Filed NDA 8/27/2018 N N Tetraphase fully synthetic tetracycline eravacycline eravacycline Bacterial infections IV/PO Filed NDA 8/28/2018 Y N Pharmaceuticals antibiotic optum.com/optumrx 2 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Non-small cell lung PF-06463922 lorlatinib Pfizer tyrosine kinase inhibitor PO Filed NDA 8/29/2018 Y N cancer (NSCLC) Familial ISIS 304801 chylomicronemia (ISIS- volanesorsen Ionis antisense drug SC Filed NDA 8/30/2018 Y Y syndrome (FCS)/ APOCIIIRx) Lipodystrophy Attention deficit SEP-225289 Sumitomo hyperactivity disorder (DSP-225289, dasotraline Dainippon/ triple reuptake inhibitor PO Filed NDA 8/30/2018 N N (ADHD)/ Eating SEP-289) Sunovion disorders damoctocog alfa BAY94-9027 Bayer anithemophilic factor Hemophilia IV Filed BLA 8/31/2018 Y N pegol Non-small cell lung PF-00299804 dacomitinib Pfizer pan-HER inhibitor PO Filed NDA 9/4/2018 Y N cancer (NSCLC) Cutaneous T-cell AMG-761 (KW- Kyowa Hakko CCR-4 chemokine receptor lymphoma (CTCL)/ mogamulizumab IV Filed BLA 9/4/2018 Y Y 0761, KM-8761) Kirin antibody Adult T-cell leukemia- lymphoma (ATCL) calcitonin gene-related TEV-48125 fremanezumab Teva/ Otsuka peptide (CGRP) receptor Migraine prevention SC Filed BLA 9/16/2018 N N antagonist amikacin liposome ALIS inhalation Insmed aminoglycoside Bacterial infections INH Filed NDA 9/28/2018 Y Y suspension Vibex QST (QuickShot testosterone Antares androgen Hypogonadism SC Filed NDA 9/29/2018 N N Testosterone) ArQule/ Daiichi c-Met receptor tyrosine ARQ-197 tivantinib Hepatic cancer PO InTrial 4Q2018 Y N Sankyo kinase inhibitor salmon calcitonin Tarsa/ Unigene Tbria osteoclast inhibitor Osteoporosis PO Filed NDA 4Q2018 N N (TAR01-201) Laboratories optum.com/optumrx 3 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug VRS-317 Versartis/ Short stature/ Growth somavaratan growth hormone analog SC InTrial 4Q2018 Y Y (hGH-XTEN) Amunix hormone deficiency Seysara sarecycline Allergan/ Paratek tetracyclines Acne vulgaris PO Filed NDA 4Q2018 N N Vernalis/ Tris CCP-07 CCP-07 undisclosed Cough and cold PO CRL 4Q2018 N N Pharma FMX-102 minocycline Foamix tetracyclines Impetigo TOP InTrial 4Q2018 N N (FXFM-244) Vernalis/ Tris CCP-08 CCP-08 undisclosed Viral rhinitis PO CRL 4Q2018 Y N Pharma PTK-0796 (MK- 2764, BAY-73- omadacycline Paratek aminomethylcyclines (AMC) Bacterial infections IV/PO Filed NDA 4Q2018 N N 7388, BAY-73- 6944) Nestorone/ Nestorone/ ethinyl progestin/ estrogen receptor Allergan Pregnancy prevention VA Filed NDA 4Q2018 N N ethinyl estradiol estradiol agonist human monoclonal anti-IL-1 Acute coronary ACZ-885 canakinumab Novartis SC Filed BLA 4Q2018 Y N beta antibody syndrome (ACS) Seciera Auven cyclosporine immunosuppressant Dry eyes OP Filed NDA 4Q2018 Y N (OTX-101) Therapeutics Loxo Oncology/ LOXO-101 larotrectinib tyrosine kinase inhibitor Solid tumors/ Sarcoma PO Filed NDA 4Q2018 Y Y Bayer Inbrija levodopa Acorda antiparkinson Parkinson's disease INH Filed NDA 10/5/2018 N N dopamine receptor APD-421 amisulpride Acacia Nausea/ Vomiting IV Filed NDA 10/5/2018 N N antagonist IPI-145 phosphatidylinositol 3 kinase Chronic lymphocytic duvelisib Verastem/ Infinity PO Filed NDA 10/5/2018 Y Y (INK-1197) inhibitor leukemia (CLL) halobetasol IDP-122 Valeant corticosteroid Psoriasis TOP Filed NDA 10/5/2018 N N propionate IONIS-TTRrx Ionis/ Akcea Transthyretin (TTR) inotersen antisense RNA modulator SC Filed NDA 10/6/2018 Y Y (ISIS-TTRRx, Therapeutics amyloidosis/ optum.com/optumrx 4 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug ISIS-420915; Transthyretin (TTR) GSK-2998728) cardiomyopathy doravirine/ non-nucleoside reverse lamivudine/ transcriptase inhibitor Human MK-1439A tenofovir Merck (NNRTI)/ nucleoside reverse immunodeficiency virus PO Filed NDA 10/23/2018 Y N disoproxil transcriptase inhibitor (HIV) fumarate (NRTI)/ NRTI non-nucleoside reverse Human MK-1439 doravirine Merck transcriptase inhibitor immunodeficiency virus PO Filed NDA 10/23/2018 Y N (NNRTI) (HIV) estrogen receptor TX-001HR estradiol/ TherapeuticsMD agonist/progesterone Menopause PO Filed NDA 10/28/2018 N N (TX-12-001HR) progesterone receptor agonist Cutaneous squamous cell carcinoma (CSCC)/ REGN-2810 Regeneron/ programmed death ligand-1 cemiplimab Non-small cell lung IV Filed BLA 10/28/2018 Y N (SAR-439684) Sanofi (PD-L1) inhibitor cancer (NSCLC)/ Basal cell carcinoma (BCC) TRV-130 oliceridine Trevena opioid receptor agonist Pain IV Filed NDA 11/2/2018 N N ARX-04 sufentanil AcelRx opioid analgesic Pain SL Filed NDA 11/3/2018 Y N fluocinolone Durasert Alimera/ pSivida corticosteroid Posterior uveitis INJ Filed NDA 11/5/2018 Y N acetonide Theravance Chronic obstructive TD-4208 long-acting muscarinic revefenacin Biopharma/ pulmonary disease INH Filed NDA 11/13/2018 N N (GSK-1160724) antagonist (LAMA) Mylan (COPD) Zemcolo DNA-dependent RNA rifamycin Cosmo/ Dr. Falk Traveler's diarrhea PO Filed NDA 11/16/2018 N N (Aemcolo) polymerase inhibitor Primary interferon-gamma NI-0501 emapalumab NovImmune SA hemophagocytic IV Filed BLA 11/20/2018 Y Y antagonist lymphohistiocytosis optum.com/optumrx 5 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Lambert-Eaton amifampridine BioMarin/ Firdapse potassium channel blocker myasthenic syndrome PO Filed NDA 11/28/2018 Y Y phosphate Catalyst (LEMS) gilteritinib Acute mylegenous ASP-2215 Astellas tyrosine kinase inhibitor PO Filed NDA 11/29/2018 Y Y fumarate leukemia (AML) Primatene HFA epinephrine Amphastar catecholamine Asthma INH Filed NDA Late 2018 N N Acute myeloid leukemia Cyclacel / Daiichi sapacitabine sapacitabine antimetabolite (AML)/ Non-small cell PO InTrial Late 2018 Y Y Sankyo lung cancer (NSCLC) growth hormone Helsinn / Novo Anorexia/ Cachexia FastTrk/ Adlumiz anamorelin secretagogue receptor PO Late 2018 Y N Nordisk (cancer-related) Breakthru (GHSR) agonist brincidofovir Adenovirus/ DNA-directed DNA FastTrk/ CMX-001 hexadecyloxyprop Chimerix Cytomegalovirus PO Late 2018 N Y polymerase inhibitor Breakthru yl ester (CMV)/ Smallpox CEM-101 solithromycin Cempra macrolide Bacterial infections IV/PO CRL Late 2018 N N FastTrk/ BAY-41-6551 amikacin Nektar/
Load more

Recommended publications
  • Print PDF Opens in a New Window
    CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES Informing Decisions About New Health Technologies Issue July 173 2018 Monoclonal Antibodies for Osteoarthritis of the Hip or Knee Image courtesy of iStock CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES 1 Authors: Sirjana Pant, Ke Xin Li, Melissa Severn Cite As: Monoclonal Antibodies for Osteoarthritis of the Hip or Knee. Ottawa: CADTH; 2018. (CADTH issues in emerging health technologies; issue 173). Acknowledgments: CADTH would like to acknowledge the contribution of Dr. Tom Appleton, MD, PhD, FRCPC, Assistant Professor, Rheumatologist; Department of Medicine, Department of Physiology and Pharmacology, The University of Western Ontario; Clinician Scientist, Lawson Health Research Institute; The Rheumatology Centre, St. Joseph’s Health Care London; for his review of the draft version of this bulletin. ISSN: 1488-6324 (online) Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy- makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.
    [Show full text]
  • Guidelines on Pulmonary Hypertension 2015 (TF08) - Task Force Members and Additional Contributors
    Guidelines on Pulmonary Hypertension 2015 (TF08) - Task Force Members and Additional Contributors For ESC Guidelines: The report below lists declarations of interest as reported to the ESC by the experts covering the period of the Guidelines production, from Task Force creation to publication. Expert Type of Relationship with Industry Beghetti Maurice A - Direct Personal payment: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. - Novartis : Pulmonary hypertension imatinib (2012) - Pfizer : Pulmonary hypertension sildenafil (2012-2013) - Bayer Schering Pharma : Pulmonary hypertension riociguat (2012-2013-2014-2015) - Eli Lilly : Pulmonary hypertension tadalafil (2012-2013-2014-2015) - Actelion : Pulmonary hypertension, Tracleer, Macitentan, Selexipag (2012-2013-2014-2015) - GlaxoSmithKline : pulmonary hypertension Ambrisentan (2012-2015) - Novartis : Pulmonary hypertension riociguat (2013) - GlaxoSmithKline : ambrisentan (2014) D - Research funding (departmental or institutional). - Actelion : no relation to a specific product (2012-2013) - Bayer Schering Pharma : no relation to a specific product (2014-2015) Galie Nazzareno A - Direct Personal payment: Speaker fees, Honoraria, Consultancy, Advisory Board fees, Investigator, Committee Member, etc. - Eli Lilly : pulmonary hypertension (2012-2013) - Novartis : pulmonary hypertension (2012-2013) - Pfizer : pulmonary hypertension (2012-2013) - Actelion : pulmonary hypertension (2012-2013) - GlaxoSmithKline : pulmonary hypertension (2012-2013)
    [Show full text]
  • DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
    Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic)
    [Show full text]
  • Future Diagnostic & Therapeutic Targets in Cardiorenal Syndromes
    Future Diagnostic & Therapeutic Targets in Cardiorenal Syndromes (Biomarkers, advanced monitoring, advanced imaging, novel therapies) EDGAR V. LERMA, MD Clinical Professor of Medicine Secon of Nephrology UIC/ Advocate Christ Medical Center Oak Lawn, IL May 27, 2017 Disclosure of Interests • Honoraria: UpToDate, McGraw-Hill Publishing, Elsevier Publishing, Springer Publishing, Wolters-Kluwer Publishing, ACP Smart Medicine, Emedicine • Editorial Boards: American Journal of Kidney Diseases, ASN Kidney News, Clinical Journal of the American Society of Nephrology, Clinical Reviews in Bone and Mineral Metabolism, International Urology and Nephrology, Journal of Clinical Lipidology, Prescribers Letter, Renal and Urology News, Reviews in Endocrinology and Metabolic Disorders, Seminars in Dialysis • Speaker/ Advisory Board: Astute Medical, Mallinckrodt, Otsuka Pharmaceuticals, ZS Pharma KDIGO Controversies Conference on Heart Failure in CKD May 25-28, 2017 | Athens, Greece Disclosure of ABIM Service: Edgar V. Lerma, M.D. ▪ I am a current member of the ABIM Self-Assessment Committee. ▪ To protect the integrity of certification, ABIM enforces strict confidentiality and ownership of exam content. ▪ My participation in this CME activity is allowed under ABIM policy and is subject to the following: • As a member of an ABIM test committee, I agreed to keep exam information confidential, as it is owned exclusively by ABIM. • As is true for any ABIM candidate who has taken an exam for certification, I have signed the Pledge of Honesty in which I have agreed
    [Show full text]
  • BLA 761125 Page 7
    BLA 761125 Page 7 HIGHLIGHTS OF PRESCRIBING INFORMATION -----------------------WARNINGS AND PRECAUTIONS----------------------­ These highlights do not include all the information needed to use BEOVU Endophthalmitis and retinal detachments may occur following intravitreal safely and effectively. See full prescribing information for BEOVU. injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay (5.1). BEOVU® (brolucizumab-dbll) injection, for intravitreal injection Increases in intraocular pressure (IOP) have been seen within 30 minutes of Initial U.S. Approval: 2019 an intravitreal injection (5.2). ----------------------------INDICATIONS AND USAGE-------------------------­ There is a potential risk of arterial thromboembolic events (ATE) following BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor intravitreal use of VEGF inhibitors (5.3). indicated for the treatment of Neovascular (Wet) Age-Related Macular ------------------------------ADVERSE REACTIONS-----------------------------­ Degeneration (AMD) (1). The most common adverse reactions (≥ 5%) reported in patients receiving ----------------------DOSAGE AND ADMINISTRATION----------------------­ BEOVU are vision blurred (10%), cataract (7%), conjunctival hemorrhage BEOVU is administered by intravitreal injection. The recommended dose for (6%), eye pain (5%), and vitreous floaters (5%) (6.1). BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately To report SUSPECTED ADVERSE REACTIONS, contact Novartis every 25-31 days) for the first three doses, followed by one dose of 6 mg (0.05 Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA­ mL) every 8-12 weeks (2). 1088 or www.fda.gov/medwatch. ---------------------DOSAGE FORMS AND STRENGTHS--------------------­ See 17 for PATIENT COUNSELING INFORMATION. Injection: 6 mg/0.05 mL solution for intravitreal injection in a single-dose vial (3).
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Eflapegrastim-Xnst Submitted by Spectrum Pharmaceuticals
    Anton F. Ehrhardt, PhD, VP Medical Affairs Spectrum Pharmaceuticals, Inc One Main St, 11th floor Cambridge, MA 02142 Phone: (617) 477-8091 Email: [email protected] Date of request: 31 August 2020 NCCN Guidelines Panel: Hematopoietic Growth Factors On behalf of Spectrum Pharmaceuticals, Inc., I respectfully request the NCCN Hematopoietic Growth Factors Panel review the enclosed data for inclusion of eflapegrastim-xnst (Rolontis®), a non-biosimilar long-acting G- CSF of noVel structure, as a recommendation for prophylaxis of febrile neutropenia and maintenance of scheduled dose deliVery (MGF-B). Specific Changes: 1. Addition of eflapegrastim-xnst as a recommendation for prophylaxis of febrile neutropenia and maintenance of scheduled dose deliVery (MGF-B) a. Dosing recommendation below listing of eflapegrastim-xnst: One dose of 13.2 mg (MGF-B) 2. Addition of eflapegrastim-xnst to the listing of Filgrastim, Pegfilgrastim and Tbo-filgrastim in table MGF- D (Toxicity Risks for Myeloid Growth Factors) FDA Clearance: Rolontis is undergoing FDA reView based on an original BLA#761148 for a proposed indication of: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. PDUFA for this reView is October 24th, 2020. Rationale: In support of the proposed change, data were generated in pre-clinical in-Vitro and animal model studies that indicated structure-related enhancement of potency, and increased concentrations in bone marrow compared to pegfilgrastim (Barrett 2020(reference 1)). Eflapegrastim is composed of a recombinant human G- CSF joined to an IgG4 Fc moiety Via a short polyethylene glycol linker.
    [Show full text]
  • Regeneron Needs a New Plan B for Eylea
    November 27, 2017 Regeneron needs a new plan B for Eylea Madeleine Armstrong Regeneron’s efforts to extend the lifespan of its blockbuster Eylea franchise via combinations have fallen flat again, raising the question of whether it can find anything that can best Eylea alone. With competition on the horizon from Novartis’s rival wet age-related macular degeneration (AMD) project, brolucizumab, Eylea sales are forecast to flatten after 2020 – something that Regeneron cannot now counter with combos (see table below). Regeneron’s stock was down 3% in premarket trading this morning, but the shares opened down just 1%. Investors might have been reassured by the fact that full data from the Hawk and Harrier studies of brolucizumab, released earlier this month, were not the smash hit that Novartis had hoped for. This could allow Eylea to keep its dominant position in the wet age-related macular degeneration (AMD) market for some time to come. Top wet AMD drugs in 2022 Annual indication sales ($m) Product Company Status 2016 2018e 2020e 2022e Eylea Regeneron/Bayer/Santen Pharmaceutical Marketed 3,584 3,875 4,073 3,942 Lucentis Novartis/Roche Marketed 2,354 2,271 1,924 1,460 Brolucizumab Novartis Phase III - - 319 937 Source: EvaluatePharma. And if positive, the phase III Panorama study of Eylea monotherapy in diabetic retinopathy, due to report in the first half of next year, could open up another avenue for growth for the company’s most valuable product. But even the most optimistic Regeneron bulls will have to admit that Eylea’s sales are likely to be eroded by the market entry of brolucizumab, expected in 2019 or 2020.
    [Show full text]
  • WO 2018/102397 Al 07 June 2018 (07.06.2018) W !P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/102397 Al 07 June 2018 (07.06.2018) W !P O PCT (51) International Patent Classification: John; 64 Gray Street, Arlington, Massachusetts 02476 A61K 9/133 (2006.01) A61K 9/10 (2006.01) (US). MUTAMBA, James Tendai; 70 Longfellow Road, A61K 9/127 {2006.01) Newton, Massachusetts 02462 (US). SHYAM, Rishab R.; 995 Massachusetts Avenue, Arlington, Massachusetts (21) International Application Number: 02476 (US). PCT/US2017/063681 (74) Agent: RED), Andrea L.C. et al; One International (22) International Filing Date: Place, 40th Floor, 100 Oliver Street, Boston, Massachusetts 29 November 201 7 (29. 11.201 7) 021 10-2605 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Langi English kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, (30) Priority Data: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/427,53 1 29 November 2016 (29. 11.2016) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/559,921 18 September 2017 (18.09.2017) US HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/559,967 18 September 2017 (18.09.2017) US KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (71) Applicant: PURETECH HEALTH LLC [US/US]; 501 MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Boylston Street, Suite 6102, Boston, Massachusetts 021 16 OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (US).
    [Show full text]
  • The Evolution of Heart Failure with Reduced Ejection Fraction Pharmacotherapy: What Do We Have and Where Are We Going?
    Pharmacology & Therapeutics 178 (2017) 67–82 Contents lists available at ScienceDirect Pharmacology & Therapeutics journal homepage: www.elsevier.com/locate/pharmthera Associate editor: M. Curtis The evolution of heart failure with reduced ejection fraction pharmacotherapy: What do we have and where are we going? Ahmed Selim, Ronald Zolty, Yiannis S. Chatzizisis ⁎ Division of Cardiovascular Medicine, University of Nebraska Medical Center, Omaha, NE, USA article info abstract Available online 21 March 2017 Cardiovascular diseases represent a leading cause of mortality and increased healthcare expenditure worldwide. Heart failure, which simply describes an inability of the heart to meet the body's needs, is the end point for many Keywords: other cardiovascular conditions. The last three decades have witnessed significant efforts aiming at the discovery Heart failure of treatments to improve the survival and quality of life of patients with heart failure; many were successful, Reduced ejection fraction while others failed. Given that most of the successes in treating heart failure were achieved in patients with re- Pharmacotherapy duced left ventricular ejection fraction (HFrEF), we constructed this review to look at the recent evolution of Novel drugs HFrEF pharmacotherapy. We also explore some of the ongoing clinical trials for new drugs, and investigate poten- tial treatment targets and pathways that might play a role in treating HFrEF in the future. © 2017 Elsevier Inc. All rights reserved. Contents 1. Introduction..............................................
    [Show full text]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub
    US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell.
    [Show full text]